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Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol

Sponsor
Yaounde Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03393728
Collaborator
(none)
10
Enrollment
1
Arm
12.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.

Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).

Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.

Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).

Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour rest.

The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label Before and After designOpen label Before and After design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism
Actual Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Dec 30, 2008
Actual Study Completion Date :
Sep 30, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

72-hour propanolol before specific treatment of hyperthyroidism

Drug: Propanolol
72-hour propanolol before specific treatment of hyperthyroidism
Other Names:
  • Avlocardyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate variability [72 hours]

      Sympatho vagal tone measures

    Secondary Outcome Measures

    1. Heart rate [72 hours]

      Heart rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism

    • naïve of all treatment specific for hyperthyroidism.

    • aged 18-70 years

    Exclusion Criteria:

    • Patients already under a specific treatment for hyperthyroidism

    • Patients taking beta blockers or any other cardiospecific treatment

    • Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure

    • Contraindications to the prescription of beta blockers

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yaounde Central Hospital

    Investigators

    • Study Chair: Jean Claude N Mbanya, MD, PhD, Yaounde Central Hospital and University of Yaounde 1
    • Principal Investigator: Eugène Sobngwi, Hôpital Central de Yaoundé et Université de Yaoundé 1

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sobngwi Eugene, Professor of Endocrinology and Metabolism, Yaounde Central Hospital
    ClinicalTrials.gov Identifier:
    NCT03393728
    Other Study ID Numbers:
    • YaoundeCH
    First Posted:
    Jan 8, 2018
    Last Update Posted:
    Jan 8, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Sobngwi Eugene, Professor of Endocrinology and Metabolism, Yaounde Central Hospital
    hyperthyroidism
    heart rate variability
    propanolol
    Africa
    Additional relevant MeSH terms:
    Hyperthyroidism
    Propranolol

    Study Results

    No Results Posted as of Jan 8, 2018